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Development of Minidose Inje Cocktail Method for Simultaneous Evaluating Five Cytochrome P450 Isoforms in Human

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01570569
First Posted: April 4, 2012
Last Update Posted: April 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jae-Gook Shin, Inje University
  Purpose
The investigators objectives were developing mini dose five-drug cocktail regimen to evaluate potential drug-drug interactions associated with use of a cocktail of caffeine, losartan, omeprazole, dextromethorphan, and midazolam for simultaneous assessment of CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A activities.

Condition Intervention Phase
Healthy Drug: Omeprazole Drug: Losartan Drug: Dextromethorphan Drug: Cocktail Drug: Midazolam Drug: Caffeine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Development of High-throughput Minidose Inje Cocktail Method for Simultaneous Evaluating Five Cytochrome P450 Isoforms in Human

Further study details as provided by Jae-Gook Shin, Inje University:

Primary Outcome Measures:
  • Cmax, AUC [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post‐dose ]

Enrollment: 26
Study Start Date: January 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Omeprazole Drug: Omeprazole
Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days.
Other Names:
  • The drug was made by Yuhan corp.
  • The drug was exclusively made for this study.
Drug: Cocktail

Group A : Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days.

Group B : Thirteen healthy male subjects received 100 μg midazolam and 2 mg caffeine individually followed by five-drugs cocktail every two days.

Other Names:
  • All of the drugs were made by Yuhan corp.
  • All of the drugs were exclusively made for this study.
Active Comparator: Losartan Drug: Losartan
Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days.
Other Names:
  • The drug was made by Yuhan corp.
  • The drug was exclusively made for this study.
Drug: Cocktail

Group A : Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days.

Group B : Thirteen healthy male subjects received 100 μg midazolam and 2 mg caffeine individually followed by five-drugs cocktail every two days.

Other Names:
  • All of the drugs were made by Yuhan corp.
  • All of the drugs were exclusively made for this study.
Active Comparator: Dextromethorphan Drug: Dextromethorphan
Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days.
Other Names:
  • The drug was made by Yuhan corp.
  • The drug was exclusively made for this study.
Drug: Cocktail

Group A : Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days.

Group B : Thirteen healthy male subjects received 100 μg midazolam and 2 mg caffeine individually followed by five-drugs cocktail every two days.

Other Names:
  • All of the drugs were made by Yuhan corp.
  • All of the drugs were exclusively made for this study.
Active Comparator: Caffeine Drug: Cocktail

Group A : Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days.

Group B : Thirteen healthy male subjects received 100 μg midazolam and 2 mg caffeine individually followed by five-drugs cocktail every two days.

Other Names:
  • All of the drugs were made by Yuhan corp.
  • All of the drugs were exclusively made for this study.
Drug: Caffeine
Thirteen healthy male subjects received 100 μg midazolam and 2 mg caffeine individually followed by five-drugs cocktail every two days.
Other Names:
  • The drug was made by Yuhan corp.
  • The drug was exclusively made for this study.
Active Comparator: Midazolam Drug: Cocktail

Group A : Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days.

Group B : Thirteen healthy male subjects received 100 μg midazolam and 2 mg caffeine individually followed by five-drugs cocktail every two days.

Other Names:
  • All of the drugs were made by Yuhan corp.
  • All of the drugs were exclusively made for this study.
Drug: Midazolam
Thirteen healthy male subjects received 100 μg midazolam and 2 mg caffeine individually followed by five-drugs cocktail every two days.
Other Names:
  • The drug was made by Yuhan corp.
  • The drug was exclusively made for this study.

Detailed Description:
The investigators objectives were developing minidose five-drug cocktail regimen to evaluate potential drug-drug interactions associated with use of a cocktail of caffeine, losartan, omeprazole, dextromethorphan, and midazolam for simultaneous assessment of CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A activities.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subject whose CYP2C9, CYP2C19, CYP2D6 genotype was determined

Exclusion Criteria:

  • Subject who has abnormal laboratory test results
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01570569


Sponsors and Collaborators
Inje University
Investigators
Principal Investigator: Jae Gook Shin, MD, PhD Inje University
  More Information

Responsible Party: Jae-Gook Shin, Department of Pharmacology and Pharmacogenomics Research Center, Inje University
ClinicalTrials.gov Identifier: NCT01570569     History of Changes
Other Study ID Numbers: 10-152
First Submitted: December 6, 2011
First Posted: April 4, 2012
Last Update Posted: April 4, 2012
Last Verified: April 2012

Keywords provided by Jae-Gook Shin, Inje University:
Volunteers

Additional relevant MeSH terms:
Midazolam
Caffeine
Dextromethorphan
Omeprazole
Losartan
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anti-Ulcer Agents